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Quality Assurance Specialist

San Mateo Metro Area, CA

Posted: 09/12/2019 Job Type: Scientific Job Number: JN -092019-25596


Reporting directly to member of the QA leadership team. Leads or supervises execution of assurance activities for Science Unit quality and compliance program. Provides expert advice on relevant GLP quality and compliance, as well as lab GCP, HBS and GLS as required. Responsible for expert evaluation of risk, standards and quality principles associated with regulations and standards governing pre-clinical and bioanalytical research.

Advises management and gives general assistance in relation to compliance program / risk questions/issues.

May manage administrative or contracted staff.

Typical Accountabilities

Implements and maintains effective compliance program activities for GLP research as well as assurance of lab GCP, HBS and GLS, as required

Operationally executes second line of defense responsibilities (quality assurance assessments, auditing, investigations, assurance reporting, etc.) as a lead

Provides responsive and proactive quality and compliance advice to defined customers and effectively influence assigned area by being relevant GLP expert, as well as lab GCP, HBS (Human Biological Samples) and GLS (Global Laboratory Standard) as required; drives a culture that seeks to prevent non-compliance and poor quality

Assess need for/lead in facilitating the development of and monitoring of applicable CAPA plans

Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations

Support driving and embedding a culture of ethics and integrity

Supports operational implementation of compliance objectives (aligned with Global Compliance strategy and objectives)

Performs key leadership support roles for regulatory inspections as assigned l Works with contract personnel or consultants to prepare, conduct and report assurance audits

Execute assurance and advisory activities for assigned GLP area, as well as lab GCP, HBS and GLS as required and computer systems validation.

Communicates effectively with compliance colleagues and customers and maintains robust knowledge of relevant industry information affecting compliance arena

Leads training for compliance colleagues and customers as required.

Education, Qualifications, Skills and Experience Essential:

Degree level education

GLP (21 CFR part 58)

Quality management (ie. auditing experience in the quality standards)

Experience in pharmaceuticals or a related industry

Knowledge of corporate governance, health care regulations, laws and standards

Excellent analytical, written and oral communications skills

Strong collaborative, partnering, and interpersonal skills

Strong ability to work independently

Basic project management skills

High ethical standards, trustworthy, operating with absolute discretion

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